It came up over lunch in a private dining room at Toronto’s National Club. It seems that people think there is a good book that can be written. It is not only a story of medical mystery but of politicians, avarice, ethics, irresponsible journalism and people who prey on the sick. It is also a mainly Canadian story.
But it starts in Ferrara, Italy. It was introduced by an Italian vascular surgeon, Professor Paolo Zamboni. Dr. Zamboni had a theory. He had noted that his wife and other patients with multiple sclerosis seemed to have restricted drainage of blood through the veins in their neck. He thought this lack of good drainage was causing a build-up of iron in the patient’s brain, either causing or exacerbating the MS patient’s neurological condition. He called his theory, Chronic Cerebrospinal Venous Insufficiency, or CCVSI.
As a vascular surgeon, Dr. Zamboni not only established a diagnosis of the problem, he and his team developed what they thought might be a cure. He initially used balloon angioplasty techniques to open the veins. Later, he introduced the use of metal stents to keep the veins open. Similar to the stents used to keep open the arteries of heart patients, Dr, Zamboni used them in neck veins. This procedure was dubbed the Liberation Treatment.
The only problem was that Dr. Zamboni was not doing this as a research study. There were no controls or double blind protocols. He was touting a procedure that had neither been determined to be safe nor been submitted for peer review. His only support for the theory was anecdotal reports of individuals who had the treatment and felt better.
It was not until the treatment was tried by a neurological team at the University of Buffalo in New York State—an area of the world with maybe ten times the incidence of multiple sclerosis than that of Ferrara, Italy–that Dr. Zamboni’s treatment was noticed by the news media. They were medical researchers from CTV television network in Toronto, Ontario, working on the network investigative program W5.
It was not so much the fault of the W5 program people that the story was blown out of proportion and caused the controversy that ensued. Canada’s CTV network constantly inserts self-promotion for its programs into its regular newscasts. It was the news programs on CTV that, in our view quite irresponsibly, sensationalized and promoted the Zamboni treatment. They did far too good a job of promoting the CTV W5 program.
Part of the reason for the success is that the Multiple Sclerosis Society of Canada is made up of chapters that are actually MS support groups in every major town and city across Canada. People with multiple sclerosis and their families in these support groups keep in constant communication. Because of this high level of communication, the CTV news programs attracted thousands of MS patients and their families across Canada to watch the W5 program that weekend.
After the first very enthusiastic W5 program was aired, the demand for this supposedly miracle treatment was immediate and overwhelming. The Multiple Sclerosis Society of Canada was caught in the middle. It could not retreat to acting responsibly. It was hammered by patients and their families, by contributors, by politicians and the public on both sides of the question.
And there were two sides. The medical profession saw the treatment as foolhardy and dangerous. They wanted to study it and test it before coming to a conclusion. Try to convince a person with an uncontrolled and debilitating disease that they have to wait!
As we said at the time to the heads of the Canadian MS Society: “That is your mob out there. You better get out front and lead it.”
And, to their credit, they did. Despite the controversy costing them large amounts in donations, the society set aside money to fund studies. In combination with the U.S. MS Society, some $2.4 million was immediately earmarked for studies of CCVSI and the proposed treatment. Within the year, studies were underway in Canada and the U.S.
But the controversy would not go away. Simcoe County in Ontario became the entire argument in microcosm. While no surgeon would face the ethical problems of putting a stent in neck veins, there was a local doctor in Barrie promoting CCVSI. Since the examination was not covered by the Ontario health plan, he would do the study for for a figure believed to be between $200 to $400. If he determined that you needed the Liberation Procedure, you could buy that off-shore for anywhere between $10,000 and $20,000 plus air fare and hotels.
Patients returned from these trips with stents in place. There seemed to be no post-operative procedures to follow. Some patients raved about the procedure. A few died. (Veins do not have the same characteristics as arteries to hold a stent in place.) Some complained that Canadian doctors were reluctant to treat these patients with stents in their neck veins. The controversy in Simcoe County split the chapter in half.
Simcoe County also is an area of focus for politicians. The Member of Parliament for Barrie has never met a charity that he would not use to promote himself. That person jumped into the fray with both feet. He is a Conservative but that did not stop other parties from getting in on the publicity. When two Liberal MPs, who were also medical doctors, from Toronto were in Barrie for a political event, they also jumped in, arguing for use of the Liberation Procedure. They got scorched by an annoyed local Liberal who realized they did not know what they were talking about.
After a year of controversy, W5 did a follow-up program and admitted that they might have been a bit too enthusiastic. Even the news programs, promoting W5, have been less eager to say that Dr. Zamboni’s cure is the answer. They now say the jury is still out.
Despite the recent agreement of the federal government to go along with the provinces and assist in testing the theory, the Canadian MS Society studies are well under way. Some answers should be available by summer of 2012. It is unlikely that Dr. Zamboni is going to like the answers.
(Note: The author of this article is a past president of the Multiple Sclerosis Society of Canada and served on the management committee and as chair of public education for the International Federation of Multiple Sclerosis Societies. He is not writing a book on this subject. It is a story in which nobody wins.)
Copyright 2011 © Peter Lowry
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